Originally Published MDDI December 2003
|CDRH Director David W. Feigal|
FDA has approved 15 firms to perform third-party inspections of certain medical device manufacturing facilities. The agency hopes the new program will enable more-frequent inspections, free up resources for it to better evaluate high-risk facilities, and encourage combining inspections for multiple nations.
The 15 firms, known as Accredited Persons (APs), will assess the quality systems of eligible manufacturers of Class II and III devices under 21 CFR Part 820, judge compliance with other device manufacturing requirements, and submit their findings to FDA. The agency will have the final say as to a firm's compliance.
“We'll encourage you to use this,” CDRH Director David W. Feigal Jr., MD, MPh, told the audience at October's Regulatory Affairs Professionals Society (RAPS; Rockville, MD) annual meeting in Baltimore. “Keeping up with inspections is hard for us to do, particularly for those in foreign settings. We want to create incentives for you to build a robust third-party system. Let's help it grow and get off the ground.”
To be eligible for the program, a facility's last inspection must have been classified by FDA as No Action Indicated or Voluntary Action Indicated. PMA preapproval inspections and “for cause” inspections are not eligible. The manufacturer must notify FDA of which AP it wants to use, and FDA must sign off on it. The manufacturer must market a device in the United States and also market or intend to market it in at least one foreign country. The AP must be recognized by at least one foreign country. APs must meet strict conflict-of-interest requirements in which no employee can have any financial interest in any company in any industry FDA regulates. At least every third inspection of a facility must be done by FDA.
The final condition, however, could be a stumbling block. The language of the Medical Device User Fee and Modernization Act of 2002, which created the program, states that manufacturers must show that “the laws of one of the countries in which the device is to be marketed recognize an inspection of the establishment by FDA.” No such laws exist, FDA officials said at the RAPS conference.
“Our Office of Compliance is working with the Office of Chief Counsel to address this,” John F. Stigi, director of CDRH's Division of Small Manufacturers, International, and Consumer Assistance, told the RAPS conference. “We will present these items in a guidance document.”
Once that hurdle is overcome, he said, device firms might be able to have U.S. and European inspections of U.S. facilities conducted by a third party at the same time. That could happen if the AP is also a Conformance Assessment Body under the Mutual Recognition Agreement. “The ideal is that the APs are accredited and inspecting under both systems,” Stigi said.
However, an official at one of the newly named APs cautioned industry not to expect such synergy soon. “We do believe the value will come when we roll these things together,” Paul C. Brooks, assistant vice president for BSI Inc. (Reston, VA), told the RAPS attendees. “But I think manufacturers will have to be patient for that. Initially, it is much too ambitious to combine the programs. As we get more confident in our U.S. inspections, ultimately you will get what you want. But not immediately.”
Another initial stumbling block, Brooks said, is that the qualifications for third-party inspectors are different from those who can do third-party 510(k) reviews or perform tests as part of the Mutual Recognition Agreement. “We have put a lot of value on having significant industry experience, and not necessarily concerned ourselves with academic qualifications,” he said. “Now, for the inspection program, academic qualifications are much higher. They have to be the same level as FDA. So some of our most experienced staff don't have the academic qualifications. That worries us, because we can't use some of the people we feel are the best.”
In addition to BSI, the APs are:
• AMTAC Certification Services Limited (Cheshire, UK)
• Danish Medical Devices Certification (DGM; Charlottenlund, Denmark)
• DQS GmbH (Frankfurt, Germany)
• Entela Inc. (Grand Rapids, MI)
• G-Med (Hauts-de-Seine, France)
• Intertek Testing Services NA Inc. (Boxborough, MA)
• Center for Measurement Standards/Industrial Technology Research Institute (CMS/ITRI; Hsinchu, Taiwan)
• KEMA Quality B.V. (Arnhem, The Netherlands)
• Orion Registrar Inc. (Arvada, CO)
• Quality Management Institute (QMI; Mississauga, ON, Canada)
• QS Zürich AG (Zürich, Switzerland)
• SGS United Kingdom Limited (Weston-super-Mare, UK)
• TÜV America, Inc. (Danvers, MA)
• TÜV Rheinland of North America, Inc. (Pleasanton, CA)
Training for APs will begin in January 2004, and FDA hopes to publish a guidance document on the logistics of the program before then. After a year, FDA has the option to accredit more firms for the program. More information about the program and the 15 APs can be found at www.fda.gov/cdrh/ap-inspection/ap-inspection.html#list.
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